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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
Recall Number Z-2229-2013
Classification Class II
Code Info 50324706 50324707 50324958 50325148 50326624 50336118 50336716 50336759 50337105 50337109 50337112 50339394 50339648 50339653 50339656 50339873 50341613 50343278 50344410 50346095 50350419 50352199 50357080 50358106 50358736 50359998 50361739 50362786 50363871 50366812 50368582 50370504 50372042 50374257 50376594 50378774 50380528 50382637 50384518 50386924 50388022 50390005 50390988 50392388 50395082 50395975 50396667 50398098 50401255 50402220 50404745 50406626 50406675 50408537 50411606 50414330 50415861 50417004 50418086 50422213 50428616 50429266 50429632 50436702 50436747 50436748 50438319 50438651 50438735 50438739 50438918 50445013 50446067 50446068 50446460 50446995 50448591 50450274 50451213 50453452 50453995 50456041 50456190 50457051 50458600 50462057
Product Distributed Qty 8889 US
Reason For Recall Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Event Detail

Event Id 66037
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew, Inc. Endoscopy Division
City Andover
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
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